Over the last several months, there have been three jury determinations with respect to inferior vena cava (“IVC”) filter cases. This article provides a brief update on those verdicts and the status of ongoing litigation with respect to IVC filters. If you or a loved one has had an IVC filter implanted and it has migrated or broken apart causing injury or death, call the experienced and trusted medical malpractice attorneys here at the Roger Ghai Law Offices. See our earlier discussions here and here.

IVC Litigation — Background

IVC filters are “spider-like devices” implanted in the inferior vena cava — a large vein leading up to the heart from the lower body — to trap blood clots. Blood clots are dangerous and can lead to heart attacks, strokes and pulmonary embolisms. The many thousands of plaintiffs have alleged various causes of action and have targeted two manufacturers of IVC filters, C.R. Bard, Inc. (“Bard”) and Cook Medical, Inc. (“Cook”). The claims being made and the accumulated evidence suggests that the IVC filters made by Bard and Cook are more dangerous than other IVC filters because they have a higher risk of tilting, perforating the IVC, or fracturing and migrating to the heart, lungs and other organs. A 2015 NBC news investigation is credited with triggering the lawsuits. In that report, it was disclosed the 39 people had died from complications related to the filters and that the Federal Drug Administration had received hundreds of reports of problems linked to IVC filters.

As of May 2018, Bard faced 3,834 IVC filter lawsuits had been filed against Bard and another 4,189 lawsuits had been filed against Cook. See here.

As of July 2018, Bard has lost one jury case and won another; Cook has had one case dismissed before trial in November 2017 but lost another case after a jury trial in late May 2018.

In March 2018, an Arizona jury awarded a plaintiff, Sherr-Una Booker, $1.6 million in compensatory damages and $2 million in punitive damages in her lawsuit against Bard. See news report here.

Ms. Booker had her Bard-manufactured IVC filter implanted in 2007. Specifically, Ms. Booker had a Bard G2 filter implanted. Bard manufactures several versions of the filters.

Seven years later, it was discovered that her filter had tilted and had penetrated the IVC wall and also fractured and broken apart. One “leg” — or strut of the filter — had migrated to Ms. Booker’s heart and two other struts had cut into Ms. Booker’s IVC. Ms. Booker underwent surgery in July 2014. One strut was removed, one strut remains embedded in her IVC and the attempt to remove the strut from her heart resulted in damage to her tricuspid valve. Ms. Booker had open heart surgery to repair the tricuspid valve and to remove that strut.

Plaintiff filed suit against Bard in February 2016 under Georgia law. She alleged four causes of action: strict liability design defect, negligent design, strict liability failure to warn, and negligent failure to warn. In March 2018, the jury found Defendants liable on the negligent failure to warn claim and awarded Ms. Booker $1.6 million in compensatory damages and $2 million in punitive damages.

In so holding, the court held that “sufficient evidence” existed for the jury to find that Bard’s G2 filter failed at higher rates than other filters, including other Bard filters. The court noted that Bard received reports and complaints within months after the G2 was first marketed about migration and other problems. Over the ensuing years, more complaints arrived from hospitals, physicians and patients. Further, Bard conducted its own testing and clinical trials, all of which confirmed the problems, particularly with fracturing and migration. Plaintiff also provided testimony from a Bard engineer who opined that the G2 device was badly designed which led to a higher likelihood of tilting, perforation and fracture. According to the judge, this was more than enough evidence to support the jury’s finding that, despite knowing that G2 filters placed patients at a greater risk of harm, Bard chose not to warn physicians and instead downplayed the risk. These facts justified both the award of compensatory damages and punitive damages.

By contrast, in June 2018, Bard was successful in defending against a case filed by Doris Jones. Mrs. Jones had a Bard Eclipse IVC filter implanted in 2010 due to recurrent deep vein thrombosis. Five years later, Mrs. Jones went to the emergency room with complaints of lightheadedness and arm pain. As with other cases, her Bard Eclipse filter had fractured causing a piece to block Mrs. Jones’ right pulmonary artery. Mrs. Jones underwent surgery to remove the filter and various pieces. However, the strut blocking the artery could not be removed.

Mrs. Jones and her husband filed suit asserting various claims under Georgia law including:

Failure to warn

Design defects

Misrepresentation and fraud

Negligence per se

Consumer fraud and unfair trade practices

Loss of consortium

Punitive damages

On March 12, 2018, summary judgment was granted on most of the counts. See Opinion here. In late May 2018, the Jones case went to trial on the failure to warn and design defects claims. After a 12-day jury trial, the jury returned a verdict in favor of Bard. See AJC report here. The plaintiffs plan to appeal the loss and seek a new trial.

In 2015, Houston, Texas firefighter, Jeffrey Pavlock had a Cook Celect filter implanted to prevent blood clots from reaching heart and lungs. Implantation of the Celect filter was intended to be temporary, but before it was scheduled to be removed, the filter migrated and broke apart. One strut became embedded in his IVC and was/is protruding through and became lodged adjacent to his aorta artery (the key human artery for blood movement). Mr. Pavlock has undergone two unsuccessful surgeries to remove the broken struts.

Mr. Pavlock brought suit against Cook in Texas State court alleging various claims including failure to warn and design/manufacturing defects.

On May 24, 2018, a Texas State jury returned a verdict of $1.2 million in favor of Pavlock and against Cook. The jury found that Cook was negligent in failing to give proper warning of the risks and dangers associated with the Celect filter. See reports here and here.

Georgia IVC Litigation Attorneys: Contact the Roger Ghai Law Offices

For more information, contact the Kennesaw medical device malpractice attorneys at the Roger Ghai Law Offices Our attorneys can help if you — or a loved one — has been injured as a result of complication from an IVC filter implantation. We provide legal services for the residents of Cobb County including the communities of Kennesaw, Acworth, Marietta and the surrounding areas. Click here to schedule your consultation.

Thousands of people across the nation have undergone inferior vena cava (IVC) filter surgery to prevent blood clots from entering the lungs — known as pulmonary emboli. An IVC is a type of vascular filter implanted by vascular surgeons or interventional radiologists to prevent life-threatening pulmonary emboli. The inferior cava, a large vein in the middle of the body, is an important blood vessel that brings oxygen-poor blood and waste products back to the heart. Deep vein thrombosis (DVT) is a blood clot that forms in a vein within the body. DVT happens when the blood thickens, forming a clump. More often than not the blood clot forms in a deep vein of the lower leg or thigh. Because a DVT may damage or weaken a vein, the blood clot may move and enter the lungs. This results in a pulmonary embolism — an extremely dangerous medical condition. One way to help prevent pulmonary embolisms is to surgically implant an IVC. When the IVC filter, which is a small and wiry device, is placed in the inferior vena cava the blood flows through the filter which catches the blood clots and prevents them from moving into the heart and/or lungs.

The Need for IVC Filter Placements

There are many reasons why a patient may need placement of an IVC filter. One reason is if you have a DVT or pulmonary embolism — or have had either in the past. Another reason for an IVC filter is if the patient is at a high risk of suffering a DVT. Because anything that slows the flow of blood through your veins increases the risk of DVT, there are several medical conditions that could increase a person’s risk. These include, but are not limited to:

Pregnancy;

Treatment for cancer;

Long periods of travel that limit mobility;

An injured deep vein in the leg(s);

Smoking;

Obesity;

Older age;

Recent surgery;

Mobility-limiting medical conditions; and

Inherited blood disorders.

Anticoagulants — commonly referred to as blood-thinning medicines — such as warfarin are also used to treat patients who are at high risk of pulmonary embolism. That being said, studies show that blood thinners, in and of themselves, are not enough to prevent this. Sometimes, physicians treat their patients with anticoagulants in addition to an IVC filter. Patients who have medical conditions that prevent them from safely taking blood thinning medication may have an IVC filter as their only choice to prevent against pulmonary embolisms.

IVC Risks to Patients

While all medical procedures carry some type of risk, IVC filter implantation surgeries have known to result in the following medical risks:

Excess bleeding;

Allergic reactions;

Serious infections;

Filter migration to the heart or lungs;

Placement issues;

Continued risk of blood clots;

Blocked blood flow of the vena cava; and

Damage to the blood vessel at the insertion site.

Health risks from an IVC filter implantation can vary based on the patient’s overall health, his or her age, the severity of the condition, and other risk factors. Notably, the International Journal of Anthology (IJA) analyzed the medical literature and found penetration of the inferior vena cava — a potential risk in IVC filter implantation surgery — has been linked to several injuries including the: first section of the small intestine (duodenum), the body’s main artery (aorta), small and large intestines, pancreas, renal vein, kidneys, the portal vein, diaphragm, genital and urinary system, and spinal column.

Increased Risk Over Time

While IVC filter implantation surgeries have likely helped thousands of patients, if the medical device is left inside the patient for too long — or, at least, longer than necessary — a number of medical complications may arise. Moreover, removing an IVC filter can be more complicated than other medical devices. The U.S. Food & Drug Administration has recommended that IVC filters should be removed within two months of implantation. The longer the IVC filter is in place, the FDA warns, the more susceptible the patient is to complications. In fact, IVC filters have been linked to dozens of deaths and nearly 1,000 FDA-reported adverse events. Issues include filter migration from its original placement, device fractures that result in metal fragments floating in the body and piercing other organs, among other issues. Initially, the FDA approved IVC filters as permanent medical devices that could remain in patients indefinitely. In 2010, however, the FDA advised — after receiving hundreds of adverse incident reports — the device should be removed once the filter is no longer necessary for the patient’s health.

Now, the FDA recommends temporary retrievable IVC filters should be removed between 29 and 54 days after insertion for patients who are no longer at a high risk for blood clots. The international peer reviewed medical journal, JAMA Internal Medicine, conducted a study that showed a majority of physicians are not following up with patients who have had IVC filters implanted. Furthermore, JAMA’s study found that only 24 percent of patients with IVC filters underwent retrieval surgery. Less than nine percent of IVC filter retrieval surgeries were successful. Current statistics show, however, that less than one-third of IVC filters are retrieved after implantation on average.

Medical Device Litigation

Not surprisingly, the potentially fatal complications associated with IVC filters have triggered hundreds of products liability lawsuits by injured patients and their loved ones. The majority of these cases are against manufacturing giants C.R. Bard (Bard) and Cook Medical (Cook), alleging the manufacturers knew of the IVC filters’ safety risks but hid these facts from consumers to make a profit. In fact, class action lawsuits against Bard and Cook have been filed in California, Florida and Pennsylvania. The suits seek compensation to offset costs of ongoing safety monitoring for patients living with IVC filters in a special fund. Multidistrict litigation (MDL) lawsuits have also been filed regarding IVC filters against Bard and Cook in Indiana and Arizona, respectively.

If you or someone you love suffered an injury due to an IVC filter, contact the knowledgeable attorneys at the Roger Ghai Law Offices. These skilled attorneys can evaluate your case and explain whether you can move forward with legal action. While a monetary compensation cannot change the past, it can help pay for medical expenses, pain and suffering, lost wages, and more. Click here today to schedule your initial case evaluation.

The function of retrievable inferior vena cava (IVC) filters is to prevent blood clots that have formed in a patient’s lower extremities or pelvis from going into the lungs or heart because if they do, the results could be serious and even fatal. When a blood clot travels to the lungs it is referred to as a pulmonary embolism. IVC filters are sometimes surgically implanted in patients that are at risk for developing blood clots that could be serious or life-threatening but are unable to take blood-thinning medication or have had recurring blood clotting issues despite taking this type of medication. These filters are typically surgically implanted in outpatient settings.

According to the U.S. Food & Drug Administration (FDA), the use of IVC filters has increased substantially since 2010. Indeed, just 10 years ago in 2007 nearly 170,000 IVC filters were implanted as compared to merely 2,000 in 1979. An IVC filter transports blood from the lower half of a patient’s body back into the heart.

FDA Voices Concern over IVC Filters

The FDA issued an official safety communication in 2014 to physicians implanting IVC filters in patients or those that followed a patient’s treatment who had an IVC filter surgically implanted.

The warning by the federal agency advised that once a patient was no longer at risk for pulmonary embolisms, physicians should consider having the IVC filter surgically removed. In fact, a scientific analysis conducted by the FDA noted that the benefit of removal compared to keeping an IVC filter in patients is between 29 and 54 days after implantation of the medical device.

The reasoning behind this conclusion stems from numerous adverse events reported to the FDA following IVC filter complications including: filter fracture, filter migration (or movement from original place), embolization (movement of filter fracture fragments or the entire filter to the heart or the lungs), difficulty removing the filter, and perforation of the filter. A 2013 report in the Journal of Vascular Surgery: Lymphatic Disorders published the FDA’s analysis on blood clot filter removals. According to the FDA, these adverse events may not have occurred if the IVC filters were removed from patients sooner. Consequently, the federal agency ordered manufacturers of IVC filters to collect additional medical research data regarding the use of the product in patients in order to get a clearer picture of the filter’s safety.

Blood Clot Filter Misbranding

The FDA has also investigated manufacturers wanting to produce retrievable IVC filters. Specifically, the FDA issued a warning letter to C.R. Bard, Inc. for misbranding one of its clot filter medical devices the Recovery Removal System, Model RC-15 for use with its G2 Filter and G2X Filter. The FDA has approved retrievable IVC filters to be implanted temporarily or permanently. The use of these medical devices for prevrenting recurring pulmonary embolisms has been approved by the FDA when blood thinning (anticoagulant) therapy has failed, blood thinning therapy is contraindicated (blood clots are still occurring) and/or as a required emergency intervention after a massive pulmonary embolism when conventional therapies are not expected to be helpful.

Medical Device Lawsuits

When a person is harmed by a medical device, an injured victim may file a lawsuit for monetary compensation under a product liability claim. All product liability cases resulting from injuries of a defective medical device generally allege one or more of three basic theories: defective manufacturing, defective design, and defective marketing.

Defective manufacturing: a medical device is improperly manufactured or otherwise damaged when an error occurs at the manufacturing facility, during shipping, or at the hospital or doctor’s office. This defect can happen at any point between the manufacturing facility and the place where the patient received (or was implanted) the product;

Defective design: a defectively designed medical device can be produced at the facility to the exact specifications of the product and arrive at the hospital or doctor’s office without issue but it is still unreasonably dangerous because of its inherent design. Sometimes the defect is not discovered until after the product is put out into the market and individuals start suffering harm;

Defective marketing: this defect refers to an inadequate warning, a lack of warning, a recommendation, or instruction concerning the use of the medical device. This can include failure to provide adequate warning of the dangers of using the product, sophisticated sales pitches targeting the medical industry, or improper advice given by the manufacturer, physician, sales rep or other healthcare provider.

Potential Defendants

When it comes to a product liability lawsuit involving a medical device, it is important that an injured victim identify and include all potential defendants in his or her claim. This is because under this area of the law every person or entity that is part of the product’s “distribution chain” may be named. The distribution chain is the path the medical device took from the manufacturer all the way to the consumer. Possible defendants in a medical device claim include the:

Manufacturer: typically, the manufacturer of a medical device is a large company because of the large market for these types of products and the technical specialty involved in developing the product.

Retail supplier: while most medical devices are directly delivered to patients by way of a physician or hospital facility, if the product that harmed you was purchased through a pharmacy, drug store, or other retail supplier this entity is in the product’s distribution chain and can be named as a defendant.

Testing laboratory or facility: any facility or laboratory that performed tests on the medical device prior to release on the market, particularly if they are separate and apart from the manufacturer.

Sales representative: sales representatives often approach doctors and other members of the healthcare community, including hospitals and outpatient facilities, to promote the latest medical devices and make recommendations regarding the potential use of these products. If a representative recommended a device that injured you, he or she may be added as a defendant in the lawsuit.

Physician: doctors that recommend a medical device may be held liable for failing to warn a patient of the potential dangers of using the product or providing improper instructions on how to use the product.

Hospital or clinic: because these healthcare facilities are part of the chain of distribution in a defective medical device that caused harm, they may be named as defendants in the lawsuit.

Medical Device Injury Help

If you or someone you care about has suffered medical complications from the implantation of a IVC filter, contact the skilled medical device attorneys at the Roger Ghai Law Offices. This law firm has years of experience representing the injured and will fight for you and your loved ones to obtain the monetary compensation to which you are entitled.

After a Georgia man died due to blood clots in his lungs, his widow questioned the veracity of claims that the Option ELITE IVC Filter was a safe and effective product. Her questions are well founded. IVC filters, promoted as a safe accompaniment to blood thinners for the treatment of blood clots, have been connected with a number health complications and fatalities. If you think an IVC filter insertion has caused serious health problems for yourself or a loved one, it may be worth your time to contact an experienced local personal injury attorney

What is an IVC Filter?

An inferior vena cava filter, or IVC filter, is a tiny metal device that somewhat resembles an octopus with rigid tentacles. It derives its name from the vein in which is placed, the inferior vena cava, and its function of filtering blood clots that may develop in the legs before they travel to the heart and lungs. Patients at risk for pulmonary embolism, or clots in the lungs, are typically candidates for IVC filters.

Complications of the IVC Filter

As with any surgical procedure, minor complications such as hematoma and access site bleeding are not uncommon. Infection and arterial punctures may also occur. Most patients agree that these are negligible issues. However, much more serious complications have been linked to these devices.

Migration of the filter: When a filter moves from its original position to the heart or pulmonary outflow tract, it can result to damage to the heart and lungs. Experts say it must then be removed using snares and other retrieval devices. Unfortunately, removal is not always possible.

Thrombosis: Deep Vein Thrombosis (DVT) incidents increased in patients who had IVC filters by between 13 and 44 percent according to two different studies. Ironically, this is the condition the filters were inserted to deal with initially. Patients with DVT may go on to suffer post-thrombotic syndrome, and may experience leaky or damaged valves, allowing fluid to pool. This can result in swelling, redness, cramping and pain in the affected leg. Additionally, the patient may experience ulcers.

Filter Fracture: The struts of the filters have fractured in some instances, potentially impacting its effectiveness. More importantly, pieces of the device may migrate to the heart and lungs.

IVC Perforation: Up to 95 percent of filter struts penetrate the wall of the inferior vena cava. This is generally insignificant. In some patients, however, ureteral, aortic, or duodenal penetration occurs. Lumbar vessels have been lacerated, causing massive bleeding. Organ damage and other complications have occurred. Surgical removal of the filter may be considered in such cases, but the risk of IVC punctures and perforations is a serious consideration.

Pulmonary Embolism: One study indicates the rate of pulmonary embolism after implantation to be over five percent, with a fatality rate of nearly four percent.

Infection: Although sterile techniques are used during filter insertion, bacterial infections are always a concern in surgical procedures.

Removal of devices: Although complications may indicate the removal of these devices is advisable, in some cases that is not possible due to :

The filter has become embedded;

The filter has protruded through a vessel;

The position of the filter has shifted and sits in an abnormal position;

Migration of the filter has made it impossible to safely retrieve; or

Blood clots have formed inside filters.

Legal Issues

Manufacturers of medical devices have a responsibility to patients. They must warn individuals of potential complications, represent the product truthfully, and create a product without defects that could lead to patient harm. IVC filter lawsuits are cropping up with increasing regularity based on a number of issues.

According the U. S. Food and Drug Administration, (FDA) a number of reports have been filed claiming the filters, or fragments of the filters, have travelled to the heart or lungs, causing serious and sometime fatal consequences. Furthermore, several suits allege companies were aware of the defects in the devices but refused to take them off the market, despite significant risks to patients. Lawsuits claim a number of issues, including:

Negligence

Design defects;

Improper warnings for doctors and patients;

Manufacturing defects;

Negligent misrepresentation; and

Breach of implied warranty.

A number of devices have been named in the lawsuits. Cook Medical is facing litigation based on two of its devices. Court documents assert that design flaws in certain Cook filters make the likelihood of fractures, migrations, tilting and perforations a serious problem. Cases in the suit are quickly approaching 3,000.

C.R. Bard is battling claims based on assertions that its IVC filters have fractured and migrated to the heart and lungs of numerous patients. Bard has settled a number of cases out of court, but faces over 2,000 ongoing claims. Documents reveal that Bard, too, was aware of the problems with its devices. Rather than inform the FDA or patients of concerns, Bard paid an independent consultant to study and report on the rate of fracture and migration of older and newer models of filters. The report noted that Bard filters had higher rates of complications than competing brands. What did Bard do with the report? It was distributed to select employees on a need-to-know basis.

Another company under legal scrutiny is Boston Scientific. Liability and wrongful death lawsuits assert that the placement its Greenfield Vena Cava filter in numerous patients has resulted in serious internal injuries and fatalities.

Impacts on Patients

We know that in individual settlements for undisclosed amounts, claimants have experienced a number of physical complications as a result of IVC filters being placed in their bodies. In addition to the physical trauma, patients have recovered damages for lost wages, anxiety, loss of a normal life, emotional trauma, disability and disfigurement. Furthermore, several class action suits claim that the complications associated with these filters necessitate regular monitoring, and that manufacturers should compensate anyone who has a filter for costs associated with that monitoring.

Do You Have a Claim?

If you or a loved one has experienced serious injuries or death as a result of the insertion of an IVC filter device, you may be able to collect significant damages. At the Roger Ghai Law Offices, our team understands the medical and emotional trauma you have endured. Negligent companies must be forced to pay for their mistakes. Contact us today for a personalized consultation.